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Upstream Process Development Jobs in Pennsylvania

MSD

Scientist, Bio Process

West Point, PA · On-site

Our vaccines upstream process development team develops safe, scalable, robust, cost-effective upstream processes that enable clinical and commercial manufacture of vaccines and adjuvants across all ...

MSD

Sr. Scientist, Preclinical Dev.

West Point, PA · On-site

$88K - $121K/yr

Our vaccines upstream process development team develops safe, scalable, robust, cost-effective upstream processes that enable clinical and commercial manufacture of vaccines and adjuvants across all ...

Merck & Co.

... upstream cell culture and commercialization. The position oversees a team of scientists, leads high-impact process development, and manages technology transfer and validation activities to support ...

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Upstream Process Development information

What are the key skills and qualifications needed to thrive in Upstream Process Development, and why are they important?

Success in Upstream Process Development requires a strong background in biology, biochemistry, or chemical engineering, often with an advanced degree and experience in cell culture or fermentation techniques. Familiarity with bioreactors, process control systems, and analytical instrumentation, as well as knowledge of cGMP regulations, is essential. Critical thinking, problem-solving, and effective communication are important soft skills for optimizing processes and collaborating across multidisciplinary teams. These competencies ensure efficient development of scalable production processes, maintaining product quality and regulatory compliance.

What is the difference between Upstream Process Development vs Downstream Process Development?

AspectUpstream Process DevelopmentDownstream Process Development
FocusDevelopment of cell culture, fermentation, and bioreactor processesPurification, filtration, and formulation of bioproducts
Skills & CredentialsBioprocess engineering, molecular biology, biochemistryBioprocessing, chromatography, analytical chemistry
Work EnvironmentLaboratories, bioreactors, pilot plantsPurification facilities, labs, quality control
Industry UsageBiotech, pharmaceutical manufacturingBiotech, pharmaceutical manufacturing

Upstream Process Development focuses on creating and optimizing cell culture and fermentation processes to produce bioproducts. In contrast, Downstream Process Development involves purifying and finishing these products. Both roles are essential in biopharmaceutical manufacturing and require similar scientific backgrounds, but they specialize in different stages of bioprocessing.

What is upstream process development?

Upstream process development refers to the optimization and scaling of biological production processes that occur before product harvesting. This primarily involves the cultivation of cells or microorganisms to produce a desired product, such as a protein or antibody, in bioreactors. Scientists in this field work on improving cell lines, culture media, and fermentation conditions to maximize yield and quality. Upstream process development is a critical early phase in biomanufacturing, laying the foundation for downstream processing and overall production efficiency.

What are some common challenges faced in upstream process development and how do teams typically address them?

One of the main challenges in upstream process development is optimizing cell culture conditions to consistently achieve high yields and product quality. Teams often encounter variability in biological systems and must troubleshoot issues such as contamination, scale-up inconsistencies, or nutrient limitations. Collaboration with analytical, downstream, and quality teams is essential to identify root causes and implement solutions. Regular data review meetings, cross-functional problem-solving, and continuous process improvement are standard practices to ensure robust upstream processes.
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Upstream Process Development jobs near you
Infographic showing various Upstream Process Development job openings in Pennsylvania as of June 2026, with employment types broken down into 3% As Needed, 47% Full Time, and 50% Part Time. Highlights an 91% Physical, 5% Hybrid, and 4% Remote job distribution.
Senior Scientist, Viral Upstream Process Development

Senior Scientist, Viral Upstream Process Development

CEDENT

Philadelphia, PA

$92K - $126K/yr

Full-time

Posted 16 days ago

Job description

Reporting to the Associate Director, Upstream Process Development, the Senior Scientist will contribute to upstream viral process development to bring Client's pipeline of T cell and viral vector-based products to the clinic. Responsibilities will include, but are not limited to, performing the day-to-day activities of the viral process development lab, building Client's viral manufacturing capabilities, and executing experiments to support viral process development/characterization. This role will collaborate significantly with research and analytical development teams, as well as contract development and manufacturing organizations.
Key responsibilities:
  • Contribute to the setup and organization of the Client's vector process development capabilities.
  • Develop bench scale suspension culture processes for viral vector generation within shake flasks and bioreactors through design and execution of experiments to support process characterization, and process transfer activities between the research team, TechOps, and external partners.
  • Provide experimental execution, data review and analysis, and maintenance of accurate and detailed lab notebooks.
  • Perform day-to-day activities in the vector process development lab including maintaining equipment, ordering materials and managing inventory, and preparing buffers and process aids.
  • Author and review technical documents, including but not limited to batch records, SOPs, development reports and process specific sections of regulatory documents.
  • Represent Client externally at meetings (professional associations, with regulatory bodies, etc.).
  • Serve as a PD subject matter expert on both internal and external teams (CDMO, material & equipment suppliers, etc.).
Required experience & skills:
  • Bachelor’s Degree with 10 years, Master’s Degree with 8 years or Ph.D. with 5 years in chemical engineering, biochemical engineering/bioengineering, biotechnology or related discipline
  • Hands-on experience with viral vector upstream processing, including excellent small-scale aseptic technique and expert understanding of bioreactor operation and control loops.
  • Experience implementing processes in clinical and commercial manufacturing of cell and gene therapy / biopharma products
  • Demonstrated ability to apply knowledge of cell biology, chemical engineering, or bioengineering toward process development, scale-up /scale-down and troubleshooting
  • Strong scientific reasoning, problem-solving, and applied mathematics and statistics skills, including the ability to break down complex problems into manageable hypotheses
  • Proven experience collaborating with internal and external partners
  • Ability to balance individual contributions while training and informally mentoring junior colleagues.
  • Working knowledge of GMP guidelines for clinical and commercial manufacturing
  • Proficiency in using Microsoft Word, Excel, Power Point and data analysis/presentation software such as JMP and/or GraphPad
  • Excellent interpersonal, verbal and written communication skills
  • Strong organizational & problem-solving skills, with excellent attention to detail and the proven ability to collaborate in a dynamic team environment
Preferred experience & skills:
  • End-to-end experience in plasmid and Lentivirus development and manufacturing
  • Experience with high-throughput bioreactors systems, namely AMBR, but others will be considered
  • Experience drafting CMC sections for INDs
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About Cedent

Sourced by ZipRecruiter

CEDENT strives to attract and retain the best people and provide an environment where they can all develop professionally and build a rewarding career. As a result, we create an inclusive environment that is rich in diversity, acknowledges each individual's uniqueness and promotes respect, personal achievement and stewardship. Our clients are global and so is CEDENT. We build and maintain a global workforce that includes people from different backgrounds, with a vast range of skills and experience all united by a common culture and commitment to help our clients achieve high performance. Cultivating a diverse workforce and inclusive work environment makes business sense. Our peoples varied skills are the talent engine that powers CEDENT, enabling it in turn to deliver the innovative solutions that help our clients outperform competitors.

Industry

It services

Company size

11 - 50 Employees

Headquarters location

Plano, TX, US

Year founded

2008

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